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The Current State of Biotransformation Science - Industry Survey of In Vitro and In Vivo Practices, Clinical Translation, and Future Trends.
Pharm Res
November 2024
AbbVie, Quantitative, Translational & ADME Sciences, North Chicago, IL, USA.
Article Synopsis
- Biotransformation is a crucial area within drug metabolism and pharmacokinetics that evaluates metabolites to ensure drug safety and compliance with regulatory guidelines.
- Metabolite identification (metID) scientists use various strategies to identify human metabolites early in drug development and assess exposure risks, following guidelines like the Metabolites in Safety Testing (MIST).
- A survey involving 26 pharmaceutical companies aimed to evaluate the effectiveness of current in vitro metID practices in predicting human metabolites, highlighting the need for a standardized framework and looking toward future advancements.
Biorelevant subcutaneous in vitro test predicts the release of human and fast acting insulin formulations.
Int J Pharm
April 2024
PharmBioTec GmbH, 66123 Saarbruecken, Germany; Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) and Saarland University, 66123 Saarbruecken, Germany.
The administration of insulins by subcutaneous injection is nowadays widely prevalent. The injection site is located below the dermis and composed of cells and the extracellular matrix formed of a network of macromolecules such as hyaluronic acid and collagen. Following an injection, the insulins from the formulated products are timely released as drug molecules from the injection site into systemic circulation.
View Article and Find Full Text PDFIn Vitro-In Vivo Correlations (IVIVC) for Predicting the Clinical Performance of Metronidazole Topical Creams Intended for Local Action.
Pharmaceutics
January 2023
Biopharmaceutics Research Institute, Rhodes University, Grahamstown 6139, South Africa.
The safety and efficacy of a generic medicine can be confirmed by demonstrating bioequivalence (BE) between the generic product and its reference listed drug (RLD) by measuring drug concentrations in the blood following administration. However, for topical dermatological products that are not absorbed into the systemic circulation, clinical trials in patients are required. The objective of this investigation was to use an in vitro method to predict in vivo performance by correlating in vitro release testing (IVRT) data with tape stripping (TS) data following the application of metronidazole (MTZ) creams to the skin of healthy human participants.
View Article and Find Full Text PDFDevelopment of an In Vitro System To Emulate an In Vivo Subcutaneous Environment: Small Molecule Drug Assessment.
Mol Pharm
November 2022
Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, Kansas66047, United States.
A reliable in vitro system can support and guide the development of subcutaneous (SC) drug products. Although several in vitro systems have been developed, they have some limitations, which may hinder them from getting more engaged in SC drug product development. This study sought to develop a novel in vitro system, namely, mulator of ubutaneous bsorption and elease (ESCAR), to better emulate the in vivo SC environment and predict the fate of drugs in SC delivery.
View Article and Find Full Text PDFSimulate SubQ: The Methods and the Media.
J Pharm Sci
June 2023
National University of Singapore, Faculty of Science, 4 Science Drive 2, 117544 Singapore. Electronic address:
For decades, there has been a growing interest in injectable subcutaneous formulations to improve the absorption of drugs into the systemic circulation and to prolong their release over a longer period. However, fluctuations in the blood plasma levels together with bioavailability issues often limit their clinical success. This warrants a closer look at the performance of long-acting depots, for example, and their dependence on the complex interplay between the dosage form and the physiological microenvironment.
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